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A Study of LUT014 in Patients With Metastatic Colorectal Cancer With EGFR Inhibitor Induced Acneiform Lesions

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ClinicalTrials.gov Identifier: NCT03876106
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Lutris Pharma Ltd.

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date March 18, 2019
Estimated Study Start Date  ICMJE March 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
Safety and tolerability (maximum tolerated dose, MTD) of LUT014 topically applied qd for 4 weeks in metastatic colorectal cancer (mCRC) patients with epidermal growth factor receptor inhibitor (EGFRI) induced acneiform lesions. [ Time Frame: From Day 0 (following administration of the first dose of study drug) through the Day 55 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03876106 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • Maximum concentration (Cmax) in plasma after a single administration and after qd administrations for 8 days [ Time Frame: Pre-dose through Day 8 ]
  • Time to maximum concentration (Tmax) in plasma after a single administration and after qd administrations for 8 days [ Time Frame: Pre-dose through Day 8 ]
  • Area under the concentration-time curve from time zero to last measurable concentration (AUC0-T) [ Time Frame: Pre-dose through Day 8 ]
  • Area under the concentration-time cure from time zero extrapolated to infinity (AUC0-∞) [ Time Frame: Pre-dose through Day 8 ]
  • Plasma elimination half-life (t1/2) [ Time Frame: Pre-dose through Day 8 ]
  • Plasma clearance (CL) [ Time Frame: Pre-dose through Day 8 ]
  • Volume of distribution (Vd) [ Time Frame: Pre-dose through Day 8 ]
  • NCI, Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 skin and subcutaneous tissue disorders grading scale performed locally by the Investigator [ Time Frame: Pre-dose through Day 55 ]
    The scale contains 5 grades from 1 which demonstrates the mild form of the disease up to 5, defined as death.
  • MASCC Study Group EGFRI-dermatologic AE grading by central reader based on photographs [ Time Frame: Pre-dose through Day 55 ]
  • Functional Assessment of Cancer Therapy-EGFRI 18 (FACT-EGFRI-18) on health-related quality of life (HRQoL) questionnaire [ Time Frame: Pre-dose through Day 55 ]
    FACT-EGFRI-18 is a patient-reported outcomes questionnaire developed to assess the effect of EGFRI on health-related quality of life The questionnaire includes 18 questions, each should be graded from 0, not suffering from this side effect at all, up to 4, suffering greatly from this side effect
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Maximum concentration (Cmax) in plasma after a single administration and after qd administrations for 8 days [ Time Frame: Pre-dose through Day 8 ]
  • Time to maximum concentration (Tmax) in plasma after a single administration and after qd administrations for 8 days [ Time Frame: Pre-dose through Day 8 ]
  • Area under the concentration-time curve from time zero to last measurable concentration (AUC0-T) [ Time Frame: Pre-dose through Day 8 ]
  • Area under the concentration-time cure from time zero extrapolated to infinity (AUC0-∞) [ Time Frame: Pre-dose through Day 8 ]
  • Plasma elimination half-life (t1/2) [ Time Frame: Pre-dose through Day 8 ]
  • Plasma clearance (CL) [ Time Frame: Pre-dose through Day 8 ]
  • Volume of distribution (Vd) [ Time Frame: Pre-dose through Day 8 ]
  • NCI CTCAE Version 5.0 skin and subcutaneous tissue disorders grading scale performed locally by the Investigator [ Time Frame: Pre-dose through Day 55 ]
  • MASCC Study Group EGFRI-dermatologic AE grading by central reader based on photographs [ Time Frame: Pre-dose through Day 55 ]
  • FACT-EGFRI-18 HRQoL questionnaire [ Time Frame: Pre-dose through Day 55 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LUT014 in Patients With Metastatic Colorectal Cancer With EGFR Inhibitor Induced Acneiform Lesions
Official Title  ICMJE A Phase 1, Open-Label, Dose Escalation Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy Study of Topically Administered LUT014 in Metastatic Colorectal Cancer Patients With EGFR Inhibitor Induced Acneiform Lesions
Brief Summary The purpose of this phase 1, multicenter study is to evaluate the safety, tolerability and preliminary efficacy of LUT014 in adult metastatic colorectal cancer patients with EGFR Inhibitor induced acneiform lesions
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
3+3 Dose escalation of LUT014
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE EGFR Inhibitor Induced Acneiform Lesions
Intervention  ICMJE Drug: LUT014
Topical
Study Arms  ICMJE
  • Experimental: LUT014 dose level 1
    LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks.
    Intervention: Drug: LUT014
  • Experimental: LUT014 dose level 2
    LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks.
    Intervention: Drug: LUT014
  • Experimental: LUT014 dose level 3
    LUT014 will be topically applied to the face, neck, and upper portion of the anterior and posterior chest once a day for 4 weeks.
    Intervention: Drug: LUT014
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with mCRC;
  • Currently being treated with an FDA approved EGFRI for the treatment of mCRC, including but not limited to Erbitux® (cetuximab) Injection and Vectibix® (panitumumab) Injection, as directed by the approved labeling;
  • Treatment with the FDA approved EGFRI initiated within 4 weeks prior to the Screening Visit;
  • Grade 1 or 2 acneiform lesions at the Screening and Baseline (Day 0) Visits;
  • Age ≥18 years at the time of signing the informed consent form (ICF);
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2;
  • Expected life expectancy greater than 3 months;
  • Subject can understand and sign the ICF, can communicate with the Investigator, can understand and comply with the requirements of the protocol, and can apply the study drug by himself/herself or has a care giver that can apply the drug;
  • Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at baseline (Day 0);
  • WCBP must agree to abstain from sex or use an adequate method of contraception from the time of informed consent through the Day 55 Visit and for 90 days after the last dose of study drug (LUT014);
  • Males must abstain from sex with WCBP or use an adequate method of contraception from the time of informed consent through the Day 55 Visit and for 90 days after the last dose of study drug (LUT014).

Exclusion Criteria:

  • Active infection;
  • Significant skin disease other than EGFRI induced acneiform lesions;
  • Any cancer other than mCRC within 3 years of Screening;
  • Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study;
  • Clinically relevant serious co-morbid medical conditions including, but not limited to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, active central nervous system (CNS) disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements;
  • Pregnant or lactating;
  • Treatment with an EGFRI other than those specified in the inclusion criteria within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
  • Treatment with a serine/threonine-protein kinase B-Raf (B-Raf) inhibitor, including but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), BraftoviTM (encorafenib), and Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug prior to Screening, whichever is longer;
  • Treatment with a systemic antibiotic within 7 days prior to Screening;
  • Treatment with a systemic corticosteroid or treatment with a topical corticosteroid to the face, neck, or upper portion of the anterior or posterior chest within 14 days prior to Screening;
  • Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer;
  • Known hypersensitivity to the inactive ingredients of the study drug (LUT014).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03876106
Other Study ID Numbers  ICMJE L-01-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lutris Pharma Ltd.
Study Sponsor  ICMJE Lutris Pharma Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lutris Pharma Ltd.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP